Z-1378-2023Class II

BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD

Name: Z-1378-2023 BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
Creator: Bio-Rad Laboratories, Inc.
Published: 2023-02-21
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2023-02-21 / Open, Classified / root cause: labeling and UDI

FDA source

Bio-Rad Laboratories, Inc. began a recall of BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD on 2023-02-21. FDA classified it as Class II and gives the reason as "Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1378-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-21
Posted: 2023-04-12
Recalling firm: Bio-Rad Laboratories Inc.
Product: BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
Product code: NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Reason for recall: Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives.There is no performance issue with the calibrator lot# 53727. They are included in the recall only because the calibrators are lot matched to the impacted reagent pack.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On February 21, 2023, Bio-Rad Laboratories issued a "Urgent: Medical Device Recall" notification to affected consignees. In addition to informing consignees about the recall, Bio-Rad asked consignees to take the following actions: 1. We are requesting that customers discontinue the use of and dispose of according to local waste management procedures any unused BioPlex 2200 Anti-CCP Reagent Pack (Catalog No. 665-3250, UDI GTIN 00847865000857) Lot No. 301481 and BioPlex 2200 Anti-CCPCalibrator Set (Catalog No. 663-3200, UDI GTIN 00847865000819) Lot No. 53727. 2. If you have distributed or transferred this product to any other Bio-Rad customers, or to any other laboratories from your site, please notify those customers of this field action. 3. Please complete the attached Customer Response Form and return it to your local Bio-Rad Technical Support so they can assist you with obtaining replacement reagent packs and calibrator sets Bio-Rad is working to provide a new lot of BioPlex 2200 Anti-CCP Reagent Pack and matching calibrator sets as soon as possible. Please provide the number of replacement units required in the attached customer response form.
Quantity in commerce: 225 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden.
Product codes and lots: Lot # 53727; UDI GTIN: 00847865000819

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1378-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1377-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1378-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12

Product code NHX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)